CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 299 enrolled
Drug / intervention
COPE-Pbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03416010
NCT03416010N/ACompleted

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT

Ohio State University·interventional·Posted Jan 30, 2018·Updated Mar 18, 2025

In Brief

A clinical study evaluating COPE-P for Emotional Disturbances and 5 related conditions. Completed, enrolled 299 participants across 3 sites.

Detailed Summary

The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 30, 2018
Enrollment StartMar 5, 2018
Primary CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.4 years ago

Interventions

COPE-Pbehavioral

Session 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave). Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones. Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses. Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication. Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle.